Companies have four Ebola vaccine candidates in the pipeline
WHO has identified an urgent need for vaccine, diagnostic and therapeutic R&D targeting the Ebola virus. The Access to Vaccines Index found that three companies evaluated had Ebola vaccine candidates in the pipeline in the period of analysis: GSK, Johnson & Johnson and Merck & Co., Inc. During the period of analysis, Pfizer discontinued its discovery stage research into Ebola.
Each company’s approach to vaccine R&D targeting Ebola demonstrates the importance of coordinated and sustained incentives for driving R&D that focuses on EIDs, as well as for ensuring that companies plan ahead to make successful candidates accessible. This is especially important given traditional vaccine development often takes between 5 and 15 years.
The case of Ebola suggests that the vaccine industry is ready to respond to incentives to engage in R&D targeting EIDs. However, it also illustrates that the established system incentivises reactive over proactive R&D. All three companies accelerated Ebola vaccine development after the West African Ebola outbreak began in 2013, in response to the global prioritisation of Ebola R&D. The scale of incentives to drive Ebola vaccine R&D was significant. All three companies collaborated with multiple stakeholders and received external funding to support vaccine development. Global health stakeholders predict that an Ebola vaccine will reach the market, but the timeframe for this is unknown. When it does occur, stakeholders envision that the vaccine will be used as part of future outbreak responses. Greater global coordination is necessary to incentivise companies to engage effectively in developing and bringing to market vaccines for a full range of EID threats.
GSK - Phase II
Partnerships and funding: In August 2014, GSK formed an international consortium to fast-track the development of its Ebola vaccine candidate (ChAd3-EBO-Z). The vaccine is being developed in collaboration with partners such as the US National Institutes of Health. The partners have committed approximately GBP 25 million in R&D funding. GSK entered into negotiations with Gavi for an APC, but ultimately no agreement was reached. GSK cited concerns that the USD 5 million payment offered by Gavi did not constitute appropriate risk-sharing, as it did not sufficiently cover manufacturing costs incurred by GSK.
Access provisions: GSK has committed to continuing to develop its Ebola vaccine at its own risk and to produce the vaccine for emergency use and stockpiling purposes. The company is considering partnerships to ensure cost will not be a barrier to access in low- and middle-income countries. GSK has also committed to supplying 300,000 doses of the vaccine to Gavi for use if an epidemic re-emerges before a vaccine is approved.
Johnson & Johnson - Phase III
Partnerships and funding: In January 2015, Johnson & Johnson announced the formation of a consortium to accelerate the development of its Ebola vaccine candidate (VAC52150), which it founded together with research institutions and non-government organisations. The consortium has received EUR 102 million in Ebola R&D funding from the Innovative Medicines Initiative (a public-private partnership). The vaccine candidate is in phase II clinical trials.
Access provisions: Johnson & Johnson will take “commercially reasonable” steps to make its vaccine available in developing countries, acting either directly or through partnerships with local authorities and international organisations (e.g., WHO, UNICEF). It applied to WHO for Emergency Use Assessment and Listing (EUAL) in September 2016, a procedure for use of vaccine candidates in the context of a public health emergency.
Partnerships and funding: Johnson & Johnson has a multivalent filovirus vaccine that moved from pre-clinical into phase I clinical development since the period of analysis ended. This project is based on AdVac® technology (prime) and Modified Vaccinia Ankara Bavarian Nordic vector (boost) and aims to protect against all filovirus strains (Ebola and Marburg). It is being developed in partnership with Bavarian Nordic and received funding from the US Department of Health and Human Services.
Access provisions: Johnson & Johnson did not disclose access provisions for this project.
Merck & Co., Inc. - Phase III
Partnerships and funding: In late 2014, Merck & Co., Inc. entered into an agreement with a biopharmaceutical company, NewLink Genetics Corporation, to develop and commercialise its Ebola vaccine candidate (rVSV-ZEBOV). It is now in clinical phase III. The company is collaborating with multiple partners to continue developing this vaccine, and has received R&D funding from donors, including several US government bodies and the Wellcome Trust. Results of a major trial in Guinea, published in December 2016, showed the vaccine was highly protective against Ebola. The vaccine will be fast-tracked for regulatory approval in the EU and US.
Access provisions: In January 2016, Merck & Co., Inc. agreed to the terms of Gavi’s APC, which was declined by GSK. It has pledged to make the vaccine available to Gavi-eligible countries “at the lowest possible access price to help achieve sustainable public sector access.”36 It has also committed to supplying 300,000 doses for emergency use and/or broader clinical trials. It applied for EUAL in December 2015.
It is not clear how each company will address the affordability of its vaccine(s) in the potential absence of a viable market.